A simple, rapid, and accurate high-performance thin-layer chromatography (HPTLC) method is described for the simultaneous determination of levofloxacin hemihydrate and ornidazole in tablet dosage form. The method is based on the HPTLC separation of the two drugs followed by densitometric measurements of their spots at 298 nm. The separation is carried out on Merck TLC aluminium sheets of silica gel 60 F254 using n-butanol-methanol-ammonia (5:1:1.5, v/v/v) as mobile phase. The linearity is found to be in the range of 50-250 and 100-500 ng/spot for levofloxacin hemihydrate and ornidazole, respectively. The method is successively applied to pharmaceutical formulation because no chromatographic interferences from the tablet excipients are found. The suitability of this HPTLC method for the quantitative determination of the compounds is proved by validation in accordance with the requirements laid down by International Conference on Harmonization (ICH) guidelines.
Lafutidine (LTD) is a histamine H2 receptor antagonist, with anti-ulcer and mucosal protective activity. A sensitive and selective stability-indicating reversed- phase high -performance thin-layer chromatography (RP-HPTLC)/Densitometry method is suggested for the determination of LTD in the presence of its acid, alkaline, oxidative and dry heat degradation products. Stress testing of LTD was done according to the International Conference on Harmonization (ICH) guidelines in order to validate the stability-indicating power of the analytical procedures. Stress testing demonstrated that LTD underwent acid, alkaline, oxidative and dry heat degradation; on the other hand, it showed stability towards neutral and photo degradation. Chromatography was performed on aluminum-backed silica gel 60 RP-18 F254 S plates with Methanol: Water: Triethylamine 8: 2: 0.5 (v/v) as mobile phase. Densitometric scanning was performed at 276 nm. The system gave compact bands for LTD (Rf 0.67 ± 0.02). Linear regression analysis data for the calibration plots discovered a good linear relationship with r2 > 0.99 in the working concentration range 500 to 3000 ng per band. The limits of detection and quantification were 23.51 ng and 71.26 ng, respectively. The developed method can routinely be used for analysis of LTD in bulk and pharmaceutical formulations
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